Xeloda and Bevacizumab to Treat Rectal Cancer

Rectal Cancer Clinical Trial

— xeberecto  

Official title:

ESTUDIO FASE II DE BEVACIZUMAB EN COMBINACIÓN CON CAPECITABINA Y RADIOTERAPIA COMO TRATAMIENTO PREOPERATORIO EN PACIENTES CON CÁNCER RECTAL LOCALMENTE AVANZADO RESECABLE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847119
• Other study ID #: ML 20006. XEBERECTO/ICO/005
• Secondary ID: EudraCT number:2
• Status: Completed
• Phase: Phase 2
• First received: February 18, 2009
• Last updated: August 28, 2017
• Start date: September 2007
• Est. completion date: February 2015

Study information

• Verified date: August 2017
• Source: Institut Català d'Oncologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The project objective is to evaluate the efficacy of the neoadjuvant treatment with bevacizumab, capecitabine and radiotherapy, in patients with rectal adenocarcinoma resectable locally advanced (stage T3 or T4), with or without presence of ganglionar metastases and without distant metastases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 2015
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. The patient has given written informed consent prior to any study related procedure

2. Male and female aged 18 to 75 years

3. ECOG performance status 0 or 1

4. Histologically confirmed diagnostic of adenocarcinoma of the rectum < 15 cm from anal verge

5. Clinical stage of T3, T4 with/without regional lymph node metastases, without metastatic disease

6. Disease evaluable by imaging techniques

7. No tumour haemorrhage in the week prior to start of study treatment

8. External derivation in symptomatic occlusive tumours

9. Not prior cancer treatment

10. Adequate bone marrow, hepatic and renal function, defined as:

1. White blood cells = 4 x 109 /l

2. Absolute neutrophil count = 1.5 x 109 /l

3. Platelets = 100 x 109 /l

4. Haemoglobin =10 g/dl

5. Bilirubin < 1.25 x upper limit of normal

6. Aspartate transaminase and alanine transaminase < 2.5 x upper limit of normal

7. Serum creatinine = 106 µmol/l

11. Less than 10% weight loss

Exclusion Criteria:

1. Rectal cancer no amenable to resection

2. Any other malignancy which has been active or treated within the past 5 years , with the exception of in situ carcinoma of the cervix and non-melanoma skin lesions adequately treated

3. Pregnant or breast-feeding women

4. Women oh childbearing potential unless effective methods of contraception are used

5. No prior or concurrent significant medical conditions, including any of the following:

• Cerebrovascular disease (including transient ischemic attack and stroke) within the past year

• Cardiovascular disease, including the following:

• Myocardial infarction within the past year

• Uncontrolled hypertension while receiving chronic medication

• Unstable angina

• New York Heart Association class II-IV congestive heart failure

• Serious cardiac arrhythmia requiring medication

6. Major trauma within the past 28 days

7. Serious nonhealing wound, ulcer, or bone fracture

8. Evidence of bleeding diathesis or coagulopathy

9. No lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication

10. No evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug

11. No known dihydropyrimidine dehydrogenase deficiency

12. Major surgery in the 4 weeks prior to the start of study treatment

13. No concurrent chronic, daily treatment with aspirin (> 325 mg/day)

14. More than 10 days since prior use of full-dose oral or parenteral anticoagulants for therapeutic purposes

15. No participation in another clinical trial with any investigational drug within 30 days prior to randomization or during study participation

16. No other medical history or condition that, in the opinion of the investigator, would preclude study participation

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Biological:
• Bevacizumab
Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg.

Drug:
• capecitabine (Xeloda)
Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period

Radiation:
• Rectal Radiotherapy
Radiotherapy in rectum 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week.

Locations

Country	Name	City	State
Spain	Institut Català d'Oncologia-L'Hospitalet	L'Hospitalet del Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Institut Català d'Oncologia	Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

References & Publications (1)

PHASE II STUDY OF PREOPERATIVE BEVACIZUMAB, CAPECITABINE, AND RADIOTHERAPY FOR RESECTABLE LOCALLY ADVANCED RECTAL CANCER. M. Martinez Villacampa, C. Santos, M. García, V. Navarro, A. Teule, F. Losa, A. Pisa, L. Lema, S. Biondo, R. Salazar. J Clin Oncol 29

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic complete response rate. % patients with pathologic complete response (absence of tumoral cells in the resected piece)		Surgery date
Secondary	Overall clinical response		Surgery date
Secondary	To determine the downstaging caused by treatment		Surgery date
Secondary	relapse free survival		Time of radiological evidence of relapse.
Secondary	Quantify the local control grade: R0 resections in surgery		Surgery date
Secondary	Local relapse and distant relapse rates		Relapse date
Secondary	To determine the security profile of this neoadjuvant treatment (radio- chemotherapy)		From date of register to surgery date
Secondary	Surgery complication rate		During surgery admission.
Secondary	To determine the angiogenic profile changes in tumour.		15 days, 6 weeks and 4 months